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Trial registered on ANZCTR


Registration number
ACTRN12623000103662
Ethics application status
Approved
Date submitted
19/11/2022
Date registered
30/01/2023
Date last updated
30/01/2023
Date data sharing statement initially provided
30/01/2023
Date results information initially provided
30/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of radiological healing in elderly hip fractures fixed with intramedullary versus extramedullary implants at 3 months
Scientific title
Assessment of radiological healing via radiological union score for hip (RUSH) score in elderly hip fractures fixed with intramedullary versus extramedullary implants at 3 months
Secondary ID [1] 308448 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
elderly hip fractures
 328251 0
Condition category
Condition code
Injuries and Accidents 325296 325296 0 0
Fractures
Musculoskeletal 325738 325738 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramedullary implant. Implant which is inserted centrally into the bone by an orthopedic surgeon.Intramedullary implant used will be proximal femoral nail or gamma nail.
Extramedullary implants used will be either dynamic hip screw, dynamic condylar screw, cannulated screws, or proximal femoral locking plate.
The procedure time will be around 1 hour. Allocation will be up to the discretion of treating surgeon.
Intervention code [1] 324895 0
Treatment: Surgery
Intervention code [2] 325029 0
Treatment: Devices
Comparator / control treatment
Extramedullary implants used will be either dynamic hip screw, dynamic condylar screw, cannulated screws, or proximal femoral locking plate
Implant which is placed eccentrically onto the bone. Intramedullary implant used will be proximal femoral nail or gamma nail. The procedure time will be around 1 hour. Allocation will be up to the discretion of treating surgeon.
Control group
Active

Outcomes
Primary outcome [1] 333157 0
Radiological healing assessed using hip x-rays in accordance with the The Radiographic Union Score for Hip (RUSH) score'
Timepoint [1] 333157 0
2 weeks post surgery, 6 weeks post surgery, 3 months post surgery (primary end-point), 6 months post surgery
Secondary outcome [1] 416000 0
pain using visual analogue scale
Timepoint [1] 416000 0
2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery

Eligibility
Key inclusion criteria
50 to 80 years old patients of both genders having hip fracture (Transcervical, Intertrochanteric and Subtrochanteric)
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of informed consent.
Unwilling/unable to comply with follow up.
Patients with polytrauma.
Patients taking steroids.
Patients taking immunosuppressants/DMARDs.
Patients with pathological fracture.
Patients unfit for surgery (ASA III and above).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
31/05/2022
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
238
Accrual to date
Final
238
Recruitment outside Australia
Country [1] 25148 0
Pakistan
State/province [1] 25148 0

Funding & Sponsors
Funding source category [1] 312693 0
Hospital
Name [1] 312693 0
Lady Reading Hospital
Country [1] 312693 0
Pakistan
Primary sponsor type
Government body
Name
Health Department Khyber Pakhtunkhwa
Address
street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa
Country
Pakistan
Secondary sponsor category [1] 314477 0
None
Name [1] 314477 0
None
Address [1] 314477 0
none
Country [1] 314477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311994 0
Instituitional Review Board, Lady Reading Hospital
Ethics committee address [1] 311994 0
street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa
Ethics committee country [1] 311994 0
Pakistan
Date submitted for ethics approval [1] 311994 0
Approval date [1] 311994 0
03/11/2020
Ethics approval number [1] 311994 0

Summary
Brief summary
The rationale of this study is to address the knowledge gap in management of hip fracture and compare the radiological healing (assessed via RUSH score) at 3 months in patients with hip fracture managed with plates and nails.
Hypothesis: There is a difference in radiological healing of hip fractures at 3 months fixed with either intramedullary or extramedullary implants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123102 0
Dr syed imran bukhari
Address 123102 0
Lady Reading Hospital, street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa
Country 123102 0
Pakistan
Phone 123102 0
+923339630619
Fax 123102 0
Email 123102 0
syedimran78@outlook.com
Contact person for public queries
Name 123103 0
Dr syed imran bukhari
Address 123103 0
Syed Imran Bukhari, street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa
Country 123103 0
Pakistan
Phone 123103 0
+923339630619
Fax 123103 0
Email 123103 0
syedimran78@outlook.com
Contact person for scientific queries
Name 123104 0
Dr syed imran bukhari
Address 123104 0
Syed Imran Bukharistreet 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa
Country 123104 0
Pakistan
Phone 123104 0
+923339630619
Fax 123104 0
Email 123104 0
syedimran78@outlook.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
local policies do not allow


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17662Ethical approval    385011-(Uploaded-19-11-2022-03-16-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4175Plain language summaryNo Out of 238 patients, 96 were males and 142 were fe... [More Details]

Documents added automatically
No additional documents have been identified.